Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-485"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2010-09-21"^^xsd:date2
dcterms:Is Part Of	lp_eu:Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)2
dcterms:Language	"pt"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-485"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-4862
lpv:speaker	lp:António Fernando Correia De Campos2
lpv:spokenAs	member; S&D (2009-07-14--2014-06-30)3 member; IMCO (2009-07-16--2012-01-18)3 substitute; ITRE (2009-07-16--2012-01-18)3 substitute; Delegation to the EU-Russia Parliamentary Cooperation Committee (2009-09-16--2014-06-30)3 unknown; Parti socialiste (2009-07-14--2014-06-30)3 member; Delegation to the EU-Chile Joint Parliamentary Committee (2009-09-16--2012-04-11)3 member; Delegation to the Euro-Latin American Parliamentary Assembly (2009-09-16--2014-06-30)3
lpv:translated text	"Mr President, the fact that there is a growing trend for the safety profile of new medicines to only become fully known after they have been put on the market means that we need a more effective pharmacovigilance system than has existed hitherto. We are facing a typical risk management problem, but we have now made it more accessible to people at a macro and supranational level. Over recent decades, new medicines have played a vital role in public health and in advances in healthcare. Adverse drug reactions, however, remain the fifth most common cause of hospital deaths. The proposals tabled reinforce the contribution of medicines to modern public health through an EU-wide pharmacovigilance system, thus improving coordination and transparency. Their aims are the monitoring, early detection, reporting and evaluation of adverse reactions. New medicines will bear a symbol saying that they are still under scrutiny. Users will be encouraged to take part in monitoring them; efficacy studies will be promoted at national level; there will be a new awareness of environmental effects; and the Union’s monitoring bodies will be enhanced in the form of the Pharmacovigilance Risk Assessment Committee (PRAC). I therefore welcome the proposals, Mr President. I congratulate the rapporteur and also the Commission on their spirit of cooperation, as well as the Spanish Presidency. I therefore welcome the proposals put forward in this legislative package and am pleased to endorse the final document to be put to the House tomorrow."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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